Trial · NCT01436162
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01436162, Phase 3, Completed, Shire; results first posted 2014-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder. Trials, record NCT01436162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01436162
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
- NCT number
- NCT01436162
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,105 participants, actual
- Lead sponsor
- Shire
- Conditions
- Major Depressive Disorder
- Interventions
- Antidepressant + SPD489 (Lisdexamfetamine dimesylate ), Antidepressant + Placebo
- First posted
- 2011-09-19
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2011-003006-25
- Results first posted
- 2014-11-07
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks | 8 weeks | MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. |
| Secondary | Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks | 8 weeks | Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. |
| Secondary | Percentage of Participants Achieving a 25% Response on the MADRS | Up to 8 weeks | The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2). |
| Secondary | Percentage of Participants Achieving a 50% Response on the MADRS | Up to 8 weeks | The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2). |
| Secondary | Percent of Participants Achieving Remission on the MADRS | Up to 8 weeks | MADRS remission was defined as a MADRS total score of ≤10. |
| Secondary | Mean Change From Baseline Over Time in MADRS Total Score | Up to 8 weeks | MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. |
| Secondary | Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores | up to 8 weeks | The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed. |
| Secondary | Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2) | Up to 8 weeks | Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. |
| Secondary | Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male | Up to 8 weeks | The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning. |
| Secondary | Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female | Up to 8 weeks | The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks | 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a 25% Response on the MADRS | Up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 50% Response on the MADRS | Up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants Achieving Remission on the MADRS | Up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline Over Time in MADRS Total Score | Up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores | up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | t-score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2) | Up to 8 weeks | Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male | Up to 8 weeks | Full Analysis Set: Male subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | MEAN |
| SECONDARY | Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female | Up to 8 weeks | Full Analysis Set: Female subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8). | units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks | Antidepressant + SPD489 | -7.3 | 95% Confidence Interval -8.6 to -6.0 | units on a scale | |
| Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks | Antidepressant + Placebo | -6.8 | 95% Confidence Interval -8.1 to -5.5 | units on a scale | |
| Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks | Antidepressant + SPD489 | -4.9 | 95% Confidence Interval -5.8 to -4.0 | units on a scale | |
| Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks | Antidepressant + Placebo | -4.3 | 95% Confidence Interval -5.2 to -3.4 | units on a scale | |
| Percentage of Participants Achieving a 25% Response on the MADRS | Antidepressant + SPD489 | 68.9 | percentage of participants | ||
| Percentage of Participants Achieving a 25% Response on the MADRS | Antidepressant + Placebo | 74.2 | percentage of participants | ||
| Percentage of Participants Achieving a 50% Response on the MADRS | Antidepressant + SPD489 | 41.6 | percentage of participants | ||
| Percentage of Participants Achieving a 50% Response on the MADRS | Antidepressant + Placebo | 37.1 | percentage of participants | ||
| Percent of Participants Achieving Remission on the MADRS | Antidepressant + SPD489 | 23.0 | percentage of participants | ||
| Percent of Participants Achieving Remission on the MADRS | Antidepressant + Placebo | 17.8 | percentage of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-blind Lead-in Phase | STARTED | Antidepressant + Single-blind Placebo | 1,105 | |
| Single-blind Lead-in Phase | STARTED | Antidepressant + Double-blind SPD489 | 0 | |
| Single-blind Lead-in Phase | STARTED | Antidepressant + Double-blind Placebo | 0 | |
| Single-blind Lead-in Phase | COMPLETED | Antidepressant + Single-blind Placebo | 823 | |
| Single-blind Lead-in Phase | COMPLETED | Antidepressant + Double-blind SPD489 | 0 | |
| Single-blind Lead-in Phase | COMPLETED | Antidepressant + Double-blind Placebo | 0 | |
| Single-blind Lead-in Phase | NOT COMPLETED | Antidepressant + Single-blind Placebo | 282 | |
| Single-blind Lead-in Phase | NOT COMPLETED | Antidepressant + Double-blind SPD489 | 0 | |
| Single-blind Lead-in Phase | NOT COMPLETED | Antidepressant + Double-blind Placebo | 0 | |
| Randomized Phase | STARTED | Antidepressant + Single-blind Placebo | 397 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | SPD489 | 25 | 211 | 29 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 213 | 6 |
| other | Nasopharyngitis | Infections and infestations | SPD489 | 14 | 211 | 14 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 19 | 213 | 20 |
| other | Decreased appetite | Metabolism and nutrition disorders | SPD489 | 13 | 211 | 14 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 5 | 213 | 5 |
| other | Headache | Nervous system disorders | SPD489 | 25 | 211 | 32 |
| other | Headache | Nervous system disorders | Placebo | 16 | 213 | 22 |
| other | Insomnia | Psychiatric disorders | SPD489 | 11 | 211 | 14 |
| other | Insomnia | Psychiatric disorders | Placebo | 7 | 213 | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SPD489 | 72 | 211 |
| Total, other adverse events | Placebo | 46 | 213 |
| Total, serious adverse events | SPD489 | 1 | 211 |
| Total, serious adverse events | Placebo | 1 | 213 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27474961 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SPD489 vs Placebo: serious adverse events |
Source Trial comparisons
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Tower Planning | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01436162
GET https://conductscience.org/api/trials/v1/NCT01436162/results?page=2